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Manager, Nonclinical Operations

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Kailera Therapeutics

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Location:
United States , Waltham

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Contract Type:
Not provided

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Salary:

110000.00 - 140000.00 USD / Year

Job Description:

We are seeking a highly organized and detail-oriented professional to join our Non-Clinical Development team. This individual will provide operational and administrative support across all aspects of non-clinical development, ensuring smooth execution of studies and team deliverables. The role is cross-functional, requiring close collaboration with internal stakeholders (finance, legal, program management, research teams) and external vendors/CROs. The successful candidate will be proactive, resourceful, and comfortable managing multiple priorities in a fast-paced environment.

Job Responsibility:

  • Maintain and monitor non-clinical study timelines, proactively flagging risks or delays to relevant stakeholders
  • Provide operational support for DMPK and bioanalytical studies
  • Manage inventory of critical reagents, internal standards, and other materials for DMPK and bioanalytical needs
  • Coordinate ordering of necessary study materials in collaboration with procurement
  • Liaise with study directors and CROs to support project execution
  • Track study milestones and deliverables for internal reporting and management
  • Support the drafting, review, and execution of contracts, work orders, and amendments with CROs and external partners
  • Act as the primary liaison between the non-clinical team, legal, and procurement to facilitate timely contract execution
  • Maintain vendor relationship tracking and ensure CRO compliance with company policies
  • Work with US and internationally based CROs in the conduct of nonclinical studies
  • Prepare and submit purchase order (PO) requests for non-clinical activities
  • Track invoices and ensure timely payment in coordination with the finance department
  • Support budget tracking and forecasting for all non-clinical studies
  • Effectively engage with the Finance department to maintain alignment with Non-Clinical Development budget forecasting and maintenance
  • Serve as a central point of contact for operational needs of the non-clinical development team
  • Support the preparation of team presentations, reports, and trackers
  • Organize team meetings, take minutes, and ensure timely follow-up on action items
  • Assist with regulatory and submission readiness activities as needed

Requirements:

  • 6+ years of experience in pharmaceutical/biotech operations, nonclinical development, or project coordination
  • Demonstrated strong organizational skills with the ability to effectively manage multiple tasks and competing priorities simultaneously
  • Excellent verbal and written communication and interpersonal skills, with the ability to work effectively with cross-functional teams and external vendors
  • Familiarity with contracts, budgets, and financial systems (e.g., invoice tracking, purchase orders, etc.)
  • Proficiency in Microsoft Office Suite (Excel, PowerPoint, Word)
  • Bachelor’s degree with 6+ years of relevant experience, or an advanced degree (MS) with experience in Toxicology, Pharmacology, or a related discipline

Nice to have:

  • Experience with project management tools is a plus
  • Knowledge of GLP and the overall drug development process is strongly preferred
What we offer:
  • Comprehensive health coverage
  • Flexible time off
  • Paid holidays
  • Year-end shutdown
  • Monthly wellness stipend
  • Generous 401(k) match
  • Tuition reimbursement
  • Commuter benefits
  • Disability and life insurance
  • Annual bonus opportunities
  • Equity grants

Additional Information:

Job Posted:
January 03, 2026

Employment Type:
Fulltime
Work Type:
Hybrid work
Job Link Share:

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